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MSCs For Treatment of Azoospermic Patients

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2016 by Sayed Bakry, Al-Azhar University
Cairo University
Information provided by (Responsible Party):
Sayed Bakry, Al-Azhar University Identifier:
First received: December 13, 2013
Last updated: June 28, 2016
Last verified: June 2016
In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic patients in a trial to enhance and activate the spermatogonial stem cells of the testis and aiming to produce motile sperm.

Condition Intervention Phase
Male Infertility Biological: Stem Cells Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Using of Bone Marrow Derived Mesenchymal Stem Cells For Treatment of Azoospermic Patients

Resource links provided by NLM:

Further study details as provided by Sayed Bakry, Al-Azhar University:

Primary Outcome Measures:
  • All Cases Improvement [ Time Frame: One Year (12-Month) ]
    Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency.

Secondary Outcome Measures:
  • All Cases Fertility Improvement [ Time Frame: One Year (12-Month) ]
    Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin) Testicular size and Sexual Potency.

Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Laboratory and Clinical
60 ml of Bone marrow will aspirated for stem cells isolation and preparation. 5 ml of stem cells prepared according to GMP rules injected into rete testis.
Biological: Stem Cells
60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally injected into rete testis.
Other Names:
  • Stem Cell Dose
  • 3-5 Million Autologous MSCs Injected into rete testis.

Detailed Description:
Bone marrow aspirated and stem cells were isolated, cultured and characterized using flow cytometer. Stem cells prepared according to GMP regulations then injected into rete testis using special syringe. Patients follow up will carried out for a year , three month interval. FSH, testosterone, testicular size as well as sexual potency will assessed every three months.

Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All Non obstructive Azoospermic Patients.
  • Azoospermic Patients due to Administration of Chemo/Radiotherapy.

Exclusion Criteria:

  • Patients with Testicular Cancer.
  • Patients with Complete Deletion of Chromosome Y AZF (a,b,c) Regions.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02025270

Contact: Taimour M Khalifa, MD +201222115517
Contact: Sayed Bakry, PhD +201006609978

Al Azhar University , School of Medicine Recruiting
Nasr City, Cairo, Egypt, 11884
Contact: Sayed Bakry, PhD    +201006609978   
Principal Investigator: Taimour Khalifa, MD         
Sub-Investigator: Sayed Bakry, PhD         
Sub-Investigator: Hala Gabr, MD         
Sub-Investigator: Wael Abu El Khier, MD         
Sponsors and Collaborators
Al-Azhar University
Cairo University
Principal Investigator: Taimour M Khalifa, MD Professor Al-Azhar University
Study Director: Sayed Bakry, PhD Al-Azhar University
Study Chair: Hala Gabr, MD Cairo University
Study Chair: Wael Abu Elkhier, MD Miltary Academy
Study Chair: Saad Moneer, MSc Al-Azhar University
Study Chair: Yasser Aly Elsheikh, MD Chairman of Urology & Andrology Department- Al Galaa Military Complex
Study Chair: Ahmed Kadeh, MSc Al-Azhar University
  More Information

Responsible Party: Sayed Bakry, Associate Professor , Consultant of Separation and Culturing of Stem Cells, Al-Azhar University Identifier: NCT02025270     History of Changes
Other Study ID Numbers: AZH010066099
Azhar23052011 ( Other Grant/Funding Number: Al Azhar University )
Study First Received: December 13, 2013
Last Updated: June 28, 2016
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by Sayed Bakry, Al-Azhar University:
Azoospermia, Spermatogonial Arrest, Maturation Arrest.

Additional relevant MeSH terms:
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female processed this record on June 23, 2017